EXTRA STRENGHT HEADACHE RELIEF

Product NDC
68210-4138
11-digit product format
682104138
Labeler code
68210
Product ID
68210-4138_ee8ee996-bec5-9717-e053-2995a90a99ed
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, ASPIRIN, CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4138-2EXTRA STRENGHT HEADACHE RELIEF1 in 1 CARTONTABLET16
68210-4138-2EXTRA STRENGHT HEADACHE RELIEF24 in 1 BOTTLETABLET246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4138EXTRA STRENGHT HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [SPIRIT PHARMACEUTICAL LLC]6Legacy NDC, 2 package rows20250101_8534a5e2-0081-477f-95ac-be0ca31c7ed7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN8534a5e2-0081-477f-95ac-be0ca31c7ed76
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD8534a5e2-0081-477f-95ac-be0ca31c7ed76
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY8534a5e2-0081-477f-95ac-be0ca31c7ed76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4138-2682104138021 BOTTLE in 1 CARTON (68210-4138-2) > 24 TABLET in 1 BOTTLE1 bottle2021-04-280000-00-00NoNoCurrent